Modafinil (sold by Cephalon under the tradename PROVIGIL) is a drug that is used to promote wakefulness, alertness and/or cognitive acuity. Side effects to systemic administration include upset stomach, diarrhea, chest pain, allergic reactions, headache, nervousness, dizziness and anxiety. Modafinil has been subject to a variety of formulations, e.g. U.S. Pat. No. 6,489,363, and intranasal delivery of modafinil has been proposed, e.g. Lawyer, et al. US 2003/0171439; however such conventional intranasal delivery provides unsatisfactory efficacy, requires undesirably large dosages, and yields poor brainiblood delivery ratios.
Inventor Frey has coauthored related issued, published and pending patent applications, including WO/2008/049588 related to intranasal delivery of poorly-water soluble compounds to the brain using lipid formulations, and U.S. Pat. Nos. 5,624,898; 6,180,603; 6,313,093; 6,342,478; 6,407,061; 6,991,785; 7,084,126; PCT publications WO91/07947; WO 00/33813; WO00/33814; WO01/41782; WO02/32449; WO02/086105; WO03/072056; and U.S. patent application/Pub Ser. Nos. 09/458,566; 09/458,562; 20030072793; 20020072498; 20020082215; 20020169102; 60/285,319; 60/288,716; 60/601,547; 2006/0188496; 2007/0092500; 2007/0054843; 20070093420.